Effect of Intramuscular Ketamine versus Haloperidol on Short-Term Control of Severe Agitated Patients in Emergency Department; A Randomized Clinical Trial

Heydari, Farhad; Gholamian, Alireza; Zamani, Majid; Majidinejad, Saeed

doi:10.29252/beat-060404

Cited by 25 publications

(9 citation statements)

References 25 publications

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“…In our trial, patients did not receive a second dose of study medications, and the need for rescue sedation was similar between trial groups. While our sedation times appear roughly similar, Heydari 31 did not employ standardized adverse event or serious adverse event reporting. However, 9 patients (10%) required endotracheal intubation (6 ketamine; 3 haloperidol), and we cannot account for the substantial difference in patient safety profile compared to our results, except that we did not permit additional dosing.…”

Section: Discussionmentioning

confidence: 83%

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Rapid Agitation Control With Ketamine in the Emergency Department: A Blinded, Randomized Controlled Trial

Barbic

Andolfatto

Grunau

et al. 2021

Annals of Emergency Medicine

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We hypothesized that the use of intramuscular ketamine would result in a clinically relevant shorter time to target sedation.Methods: We conducted a randomized clinical trial comparing the rapidity of onset, level of sedation, and adverse effect profile of ketamine compared to a combination of midazolam and haloperidol for behavioral control of emergency department patients with severe psychomotor agitation. We included patients with severe psychomotor agitation measured by a Richmond Agitation Score (RASS) þ3. Patients in the ketamine group were treated with a 5 mg/kg intramuscular injection. Patients in the midazolam and haloperidol group were treated with a single intramuscular injection of 5 mg midazolam and 5 mg haloperidol. The primary outcome was the time, in minutes, from study medication administration to adequate sedation, defined as RASS -1. Secondary outcomes included the need for rescue medications and serious adverse events.Results: Between June 30, 2018, and March 13, 2020, we screened 308 patients and enrolled 80. The median time to sedation was 14.7 minutes for midazolam and haloperidol versus 5.8 minutes for ketamine (difference 8.8 minutes [95% confidence interval (CI) 3.0 to 14.5]). Adjusted Cox proportional model analysis favored the ketamine arm (hazard ratio 2.43, 95% CI 1.43 to 4.12). Five (12.5%) patients in the ketamine arm and 2 (5.0%) patients in the midazolam and haloperidol arm experienced serious adverse events (difference 7.5% [95% CI -4.8% to 19.8%]). Conclusion:In ED patients with severe agitation, intramuscular ketamine provided significantly shorter time to adequate sedation than a combination of intramuscular midazolam and haloperidol. [

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Section: Discussionmentioning

confidence: 83%

“…Heydari 31 randomized 90 patients to ketamine (4 mg/ kg) or haloperidol (5 mg) alone and achieved a ketamine sedation time of 7.7 minutes. However, additional half doses of the study drug were commonly administered (ketamine group 64%; haloperidol group 51%).…”

Section: Discussionmentioning

confidence: 99%

Rapid Agitation Control With Ketamine in the Emergency Department: A Blinded, Randomized Controlled Trial

Barbic

Andolfatto

Grunau

et al. 2021

Annals of Emergency Medicine

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“…1. The articles excluded by full text review are listed in Supplementary Material B. Eleven trials [22][23][24][25][26][27][28][29][30][31][32] including 27 study arms remained eligible after systematic review. Ten intramuscular drug/drug combinations were available for comparison, and haloperidol (6 trials) and midazolam (5 trials) were most frequently investigated.…”

Section: Study Selectionmentioning

confidence: 99%

“…Eleven studies [22][23][24][25][26][27][28][29][30][31][32] that randomized 1142 patients among 11 drug treatments (including intravenous valproate) provided data for effectiveness. Eleven studies [22][23][24][25][26][27][28][29][30][31][32] that randomized 1147 patients among 11 drug treatments (including intravenous valproate due to its direct comparison with haloperidol in one trial [22]) provided data for safety. Six studies [23][24][25][26]28,31] that randomized 559 patients among seven drug treatments provided data for effect onset.…”

Section: Summary Of the Network Geometrymentioning

confidence: 99%

Rapid tranquilization of the agitated patient in the emergency department: A systematic review and network meta-analysis

deSouza

Thode

Shrestha

et al. 2022

The American Journal of Emergency Medicine

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“…Each syringe contained 2 mL of clear solution requiring refrigeration. We used the Altered Mental Status Scale (AMSS), a validated 14,27,28 ordinal agitation scale from −4 (coma) to 0 (normal) to + 4 (most profoundly agitated) routinely used at our institution, to quantify the severity of agitation (Table 1). Our institution is most familiar with AMSS; however, to ensure our results would be generalizable the Behavioral Activity Rating Scale (BARS; Data Supplement S1, Table S1, available as supporting information in the online version of this paper, which is available at http://onlinelibrary.wiley.com/doi/10.1111/acem.14124/full) was also recorded on each patient.…”

Section: Methodsmentioning

confidence: 99%

Randomized Double‐blind Trial of Intramuscular Droperidol, Ziprasidone, and Lorazepam for Acute Undifferentiated Agitation in the Emergency Department

Martel

Miner

Biros

et al. 2020

Academic Emergency Medicine

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Background The optimal agent to treat acute agitation in the emergency department (ED) has not been determined. The objective of this study was to compare the effectiveness and safety of intramuscular droperidol, ziprasidone, and lorazepam for acute agitation in the ED. Methods This was a randomized, double‐blind trial of ED patients with acute agitation requiring parenteral sedation. The study was conducted under exception from informed consent (21 CFR 50.24) from July 2004 to March 2005. Patients were randomized to receive 5 mg of droperidol, 10 mg of ziprasidone, 20 mg of ziprasidone, or 2 mg of lorazepam intramuscularly. We recorded Altered Mental Status Scale (AMSS) scores, nasal end‐tidal carbon dioxide (ETCO2), and pulse oximetry (SpO2) at 0, 15, 30, 45, 60, 90, and 120 minutes as well as QTc durations and dysrhythmias. Respiratory depression was defined as a change in ETCO2 consistent with respiratory depression or SpO2 < 90%. The primary outcome was the proportion of patients adequately sedated (AMSS ≤ 0) at 15 minutes. Results We enrolled 115 patients. Baseline AMSS scores were similar between groups. For the primary outcome, adequate sedation at 15 minutes, droperidol administration was effective in 16 of 25 (64%) patients, compared to seven of 28 (25%) for 10 mg of ziprasidone, 11 of 31 (35%) for 20 mg of ziprasidone, and nine of 31 (29%) for lorazepam. Pairwise comparisons revealed that droperidol was more effective that the other medications, with 39% (95% confidence interval [CI] = 3% to 54%) more compared to 20 mg of ziprasidone and 33% (95% CI = 8% to 58%) more compared to lorazepam. There was no significant difference between groups in need of additional rescue sedation. Numerically, respiratory depression was lower with droperidol (3/25 [12%]) compared to 10 mg of ziprasidone (10/28 [36%]), 20 mg of ziprasidone (12/31 [39%]), or lorazepam (15/31 [48%]). One patient receiving 20 mg of ziprasidone required intubation to manage an acute subdural hematoma. No patients had ventricular dysrhythmias. QTc durations were similar in all groups. Conclusions Droperidol was more effective than lorazepam or either dose of ziprasidone for the treatment of acute agitation in the ED and caused fewer episodes of respiratory depression.

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Effect of Intramuscular Ketamine versus Haloperidol on Short-Term Control of Severe Agitated Patients in Emergency Department; A Randomized Clinical Trial

Cited by 25 publications

References 25 publications

Rapid Agitation Control With Ketamine in the Emergency Department: A Blinded, Randomized Controlled Trial

Rapid Agitation Control With Ketamine in the Emergency Department: A Blinded, Randomized Controlled Trial

Rapid tranquilization of the agitated patient in the emergency department: A systematic review and network meta-analysis

Randomized Double‐blind Trial of Intramuscular Droperidol, Ziprasidone, and Lorazepam for Acute Undifferentiated Agitation in the Emergency Department

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